The FDA is offering a grant to support the development and qualification of a Patient Reported Outcome (PRO) tool for Non-Cystic Fibrosis Bronchiectasis (NCFB) within the Drug Development Tools Qualification Program. This grant will cover the qualitative and quantitative phases of instrument development, ultimately enhancing the design and interpretation of anti-infective clinical trials for NCFB patients. The goal is to address the current lack of optimal endpoints in these trials, aligning with the FDA’s focus on stimulating innovation for improved patient outcomes and product performance. Closing date for applications is April 4, 2019.
Opportunity ID: 312679
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-014 |
| Funding Opportunity Title: | Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 06, 2019 |
| Last Updated Date: | Feb 06, 2019 |
| Original Closing Date for Applications: | Apr 04, 2019 |
| Current Closing Date for Applications: | Apr 04, 2019 |
| Archive Date: | May 04, 2019 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $2,000,000 |
| Award Floor: | $1,000,000 |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses State governments City or township governments Special district governments County governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Higher Education Institutions• Public/State Controlled Institutions of Higher Education • Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Governments• State Governments • County Governments• City or Township Governments• Special District Governments• Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized)• U.S. Territory or PossessionOther• Independent School Districts• Public Housing Authorities/Indian Housing Authorities• Native American Tribal Organizations (other than Federally recognized tribal governments)• Faith-based or Community-based Organizations• Regional Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA)is to support research to develop and qualify a Patient Reported Outcome (PRO)for Non-Cystic Fibrosis Bronchiectasis (NCFB) under FDA’s Drug DevelopmentTools Qualification Program. This would include the qualitative phase ofdeveloping the instrument, quantitative phase of testing the instrument, andqualification of the instrument. It is expected that thisqualified PRO would help improve upon the current design, conduct, andinterpretation of anti-infective clinical trials in NCFB patients, for whichoptimal endpoints are currently lacking. This work directly aligns with FDA’sresearch area of interest to “stimulate innovation in clinical evaluations andpersonalized medicine to improve product performance and patient outcomes. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-19-014 | FORM E | PKG00248130 | Feb 06, 2019 | Apr 04, 2019 | View |
Package 1
Mandatory forms
312679 RR_SF424_2_0-2.0.pdf
312679 PHS398_CoverPageSupplement_4_0-4.0.pdf
312679 RR_OtherProjectInfo_1_4-1.4.pdf
312679 PerformanceSite_2_0-2.0.pdf
312679 RR_KeyPersonExpanded_2_0-2.0.pdf
312679 RR_Budget_1_4-1.4.pdf
312679 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
312679 RR_SubawardBudget30_1_4-1.4.pdf
312679 PHS_AssignmentRequestForm_2_0-2.0.pdf
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